March 28, 2011
A study of 231 patients demonstrated that the use of angioplasty to widen veins is a safe, minimally invasive option for individuals with multiple sclerosis (MS), according to research presented at the Society of Interventional Radiology's (SIR) 36th annual scientific meeting in Chicago. The findings open the door for further research into the clinical role of the treatment.
In a retrospective study, 231 MS patients (age range, 25 to 70 years old; 147 women) underwent 247 endovascular procedures of the internal jugular and azygos veins with or without placement of a stent.
"Our results show that such treatment is safe when performed in the hospital or on an outpatient basis—with 97 percent treated without incident," Kenneth Mandato, MD, an interventional radiologist at Albany Medical Center in Albany, N.Y., noted.
In 99 percent of procedures, patients were discharged within three hours of treatment. Complications included transient headache in 8.5 percent of patients and neck pain in 15.8 percent of patients. Sustained cardiac arrhythmias occurred in three patients. The researchers indicated that cardiac monitoring is essential for rapid treatment of procedure-induced arrhythmias and recommended post-procedure ultrasound to detect venous thrombosis.
About 500,000 people in the U.S. have MS, generally thought of as an incurable, disabling autoimmune disease in which a person's body attacks its own cells. "There are few treatment options that truly improve the quality of life of those with the disease, and some of the current drug treatment options for MS carry significant risk," said Mandato.
In 2009, Paolo Zamboni, a doctor from Italy, published a study that suggested that a blockage in the veins that drain blood from the brain and spinal cord and return it to the heart (a condition called chronic cerebrospinal venous insufficiency or CCSVI) might contribute to MS and its symptoms. The idea is that if these veins were widened, blood flow may be improved, which may help lessen the severity of MS-related symptoms.
The Society of Interventional Radiology issued a position statement last fall supporting high-quality clinical research to determine the safety and effectiveness of interventional MS treatments, recognizing that the role of CCSVI in MS and its endovascular treatment by an interventional radiologist via angioplasty or stents to open up veins could be transformative for patients. "This is an entirely new approach to the treatment of patients with neurologic conditions, such as multiple sclerosis. The idea that there may be a venous component that causes some symptoms in patients with MS is a radical departure from current medical thinking," said Gary P. Siskin, MD, an interventional radiologist and chair of the radiology department at Albany Medical Center and the co-chair of the SIR research consensus panel on MS that was held in October.
"It is important to understand that this is a new approach to MS. As a result, there is a healthy level of skepticism in both the neurology and interventional radiology communities about the condition, the treatment and the outcomes," said Siskin.
"Patients are learning about this therapy and the role of interventional radiology in venous angioplasty through the internet. They are discussing it among themselves—through blogs and social networking sites—and then turning to interventional radiologists for this treatment," he noted. "This is a new entity and one where researchers are clearly very early in their understanding of both the condition and the treatment."
While the use of angioplasty and stents cannot be endorsed yet as a routine clinical treatment for MS, SIR agrees that the preliminary research is very promising and supports studies aimed at understanding the role of CCSVI in MS, at identifying methods to screen for the condition and at designing protocols for exploratory therapeutic trials.
Mandato noted that research still needs to be done concerning patient selection, technique and the outcomes after this procedure, including improvement in symptoms and quality of life and the durability of the response.
Wednesday, March 30, 2011
Tuesday, March 29, 2011
The Druging of America
Washington D.C., March 27, 2011 – Pharmaceuticals are a $650 plus billion dollar a year industry. For years the most profitable business in the U.S. has been the pharmaceutical corporations, which routinely top the annual fortune 500 list. Doctor prescribed drugs support an industry which out-earns the GNP of many nations.
A core attribute to big Pharma’s overwhelming ‘success’ lays in the liaison between the corporations and the ‘symptoms management’ health care industry: The pharmaceutical representative. The men and women we see meeting with physicians, walking into offices with gifts of lunch for the staff, meeting with the doctor while you wait for our appointment.
Gwen Olsen
Gwen Olsen
Gwen Olsen was a top level pharmaceutical rep for some of the biggest in the industry: Johnson & Johnson, Syntex Labs, Bristol-Myers Squibb, Abbott Laboratories and Forest Laboratories.
Through some chilling wake up calls in her tenure, and the tragic drug-related death of her niece, Gwen has dedicated her life to making people aware of the dangers of prescription drugs and how the drug industry manipulates doctors into prescribing, and over prescribing, their drugs.
She is exposing the dark, deep-rooted deception and corruption that is prevalent in this industry.
Gwen Olsens words are powerful. Her message absolutely frightening. Below is a transcript of our conversation as well as a video of Gwen speaking out, including her appearance on a CBS Evening News Eye On Your Children news segment.
Adam Omkara: So you went into the industry with an altruistic mindset and you wanted to help people. When was it made apparent to you that the industry wasn’t based on that altruism, or even healing?
Gwen: Well, it was on the 2nd stage interview with the regional manager. He asked me why I wanted to get into the pharmaceutical industry. I said ‘well I really want to help people, that’s what I want to do’.
He kind of laughed, smiled, and said “Well, I’m not so sure about that. If altruism is what motivates you, then you better join the peace corp." Then he smiled, turned around to his desk and started working on his calculator. He said “however, if money is what motivates you, let me tell you how you can retire a millionaire from this job young lady.”
He went into delineating my benefits, stock options, and it all turned into a big blur for me. I saw dollar signs. It sounded pretty good to a 26 year old. So, that’s how initially I was told it wasn’t altruistic.
Adam Omkara: And you said you were actually trained to misinform people- Can you elaborate on that?
Gwen: Well, initially when you start pharmaceutical sales training you are taken into the home office for a sort of ‘indoctrination’ that’s 2-6 weeks of intensive training. That’s where the industry turns representatives into psychological profilers and people pleasers. The reps learn how to be people analyzers, so they know how to best influence people. We were taught in training sessions called ‘knee to knees’ and ‘toe to toes’ where you have a line of reps that play the doctor and opposing lines that play the rep position.
You have to learn verbatim the company’s position and their marketing lines- you can’t even vary from that. You practice and practice until it flows naturally and doesn’t sound rehearsed.
I started recognizing really that I was being trained to divert doctor’s attention away from his/her concerns. So, I was learning to misinform and disinform- to counter the doctor’s valid concerns. I wasn’t trained to say “this drug is bad for that patient” or “watch out for this drug’s interaction with that one." Any information perceived as a negative was always being candy coated.
In fact many times we would be called into a meeting when a new sales piece was being introduced. Managers would ask us questions on what aspects of the piece we received the most objections on. What were the parts that raised the most concern? After we gave the marketing department that feedback, the next period they would come up with a different layout that had manipulated and minimized the objectionable data. So, it was a constant set of circumstances where I began to see that I wasn’t allowed to give good information and I wasn’t given good information to share.
The industry knows that many of their drugs aren’t safe and that they don’t heal people. In fact, some drugs are designed to make symptoms worse later on.
When I started becoming pro-active and began to ask too many critically intelligent questions, management objected and discouraged me. I was frequently met with answers such as “We do it that way because we can", or "We sell more pills that way.”
It was apparent my inquiries were not welcomed!
It was almost like being in the military, in fact, many of my ex-managers had been in the military. Many are hired because they have great work ethics and they don’t ask a lot of questions. Military personnel are used to working on a ‘need to know’ basis.
Adam Omkara: How did you come to an awakening towards the industry. Did it all hit you all of the sudden, or was it a slow process?
Gwen: I realized early on I was in a position where I could harm people; In a position where I could literally take lives. My grand realization arrived when I started promoting a specific new drug.
I went to a national sales meeting for this new drug launch and was told the wonders on how it was going to help people. We immediately were sent out into our individual territories to get support for the new drug with key prescribing physicians.
The dark secrets of the drug industry
The dark truth of the drug industry
Drug reps are given profiles of all the physicians in the territory on what their ‘writing habits’ are, i.e. their general personality, their prescribing habits like whether they are high volume prescribers or early adopters, or late adopters/skeptics.
Reps have all this information available before making a sales call so that they know how to approach the doctor and can develop a sales strategy.
So there was one doctor in my territory that was profiled as a “late adopter/skeptic.” That meant he was going to be difficult for me to get him to prescribe my new drug.
The marketing plan developed at launch emphasized to the sales force that as a last ditch effort, if a doctor didn’t want to write prescriptions for the new product, then the rep was to ask for just one patient- the most difficult patient that the doctor had. The theory was that if the drug worked for them, then the doctor would be more likely to use it in his broader practice later.
I did my presentation and the doctor told me his policy was he didn’t prescribe a new drug until it’s been on the market for at least a year. He had been burned on new drugs before.
However, with some hesitation he agreed to try it in his most difficult patient who had failed all other therapies and I left him samples.
Some time later I got a call from my district manager. I was being sent out to gather information for an Adverse Drug Reaction (ADR) report, as there has been a death in my territory from our new drug and it was a patient of that doctor. And guess what- it was his mother! She had gone into renal failure and died from complications in dialysis. I was devastated!
After I went to get the ADR info, it took me almost 6 months to work up the nerve to go see that man again and look him in the eye. I was acutely aware that it had been my over-zealous and persistent marketing of the product that had influenced him to do something against his better judgment and, as a consequence, his own mother had paid with her life!
I’ll never forget his angry, terse remark to me, “Well, I see you all put a lot more effort into your marketing plan than you did your drug research and development!” What could I say to him after that?
That was my very first clue as a young rep that my job had serious ramifications.
Once this happened more and more things started falling into place. So with that awareness I began to see the job and industry with new eyes…
Adam Omkara: And no one seems to questions this? Why don’t you think there is more of this awakening or questioning? Representatives, psychiatrists, doctors, managers? Is there some desensitization process that comes into play that’s very effective? Where does the disconnect come into play and how is it sustained?
Gwen: Yes, there is definitely a desensitization process. A re-programming if you will. The indoctrination is usually done at the home office during the initial training and is similar to how they do boot camp in the military. They tear you down physically and psychologically, reps are kept up late nights studying for exams, preparing presentations, filming videos, deprived of sleep, deprived of good nutrition, required to dress to the nines and constantly compete with one another as they are being watched and evaluated in the corporate fish bowl.
It’s a very psychologically grueling, but effective grooming environment.
Then when they release you back into your sales territory, you have this false sense of bravado feeling like you’re someone special who is going to go out and help the world. It’s literally a brainwashing process.
What they are effectively doing is trying to weed out the mavericks and break the weak ones. The one’s who can’t handle the job long term and, therefore, will be a wasted investment.
Adam Omkara: Do you know if the same basic training policy is upheld for other companies?
Gwen: I worked for five different companies and it happened in every single one. And I was no flunkee who lost my job and then started bashing the industry. I was the best of the best and performed at the top 3% in each company that I worked for full time.
Usually, as soon as a rep starts asking too many questions or makes unnecessary waves with management they are easily dispensed of and told there are plenty more eligible people behind them waiting to take their job. The only reason I was tolerated was because of how valuable I was to them.
I always made my district and managers look good at the bottom line.
Adam Omkara: And what about the psychiatrists and that industry? Do they not question?
Gwen: You really want me to be honest? The pharmaceutical industry makes so much fun of the psychiatric profession that it’s not even funny. They actually refer to psychiatrists as ‘drug whores.’ The reason they call them that is because they have no loyalty to any one company or product, it’s whoever is paying them at the time.
I was told in the initial training I received to sell antipsychotic drugs that most psychiatrists got into the field of psychiatry in order to figure out why they were so screwed up. There were definitely some very odd birds! So yeah, they were not held in very high regard. My colleagues and I looked down on them as though they were a ‘lower class’ quasi-physician. Because we knew that they didn’t do anything scientifically, it was all subjective diagnosis in nature, dependent on third-party observation of symptoms.
So they were easy to sell drugs to. Most psychiatrists are so ego-driven they would literally recommend anything when given the appropriate sales pitch!
In this day and age, most psychiatrists don’t use talk therapy anymore- just 15 minute appointments, what are your symptoms, try this and come back in a month. You’re lucky if you can get counseling these days (under coverage) and children rarely get it.
So, you can see there is a huge incentive to continue the psychopharmacologic-based treatment paradigm. Because if this huge house of cards actually implodes there will be all these doctors that have no way to practice in psychiatry anymore. Without drug therapy, how would they practice?
A core attribute to big Pharma’s overwhelming ‘success’ lays in the liaison between the corporations and the ‘symptoms management’ health care industry: The pharmaceutical representative. The men and women we see meeting with physicians, walking into offices with gifts of lunch for the staff, meeting with the doctor while you wait for our appointment.
Gwen Olsen
Gwen Olsen
Gwen Olsen was a top level pharmaceutical rep for some of the biggest in the industry: Johnson & Johnson, Syntex Labs, Bristol-Myers Squibb, Abbott Laboratories and Forest Laboratories.
Through some chilling wake up calls in her tenure, and the tragic drug-related death of her niece, Gwen has dedicated her life to making people aware of the dangers of prescription drugs and how the drug industry manipulates doctors into prescribing, and over prescribing, their drugs.
She is exposing the dark, deep-rooted deception and corruption that is prevalent in this industry.
Gwen Olsens words are powerful. Her message absolutely frightening. Below is a transcript of our conversation as well as a video of Gwen speaking out, including her appearance on a CBS Evening News Eye On Your Children news segment.
Adam Omkara: So you went into the industry with an altruistic mindset and you wanted to help people. When was it made apparent to you that the industry wasn’t based on that altruism, or even healing?
Gwen: Well, it was on the 2nd stage interview with the regional manager. He asked me why I wanted to get into the pharmaceutical industry. I said ‘well I really want to help people, that’s what I want to do’.
He kind of laughed, smiled, and said “Well, I’m not so sure about that. If altruism is what motivates you, then you better join the peace corp." Then he smiled, turned around to his desk and started working on his calculator. He said “however, if money is what motivates you, let me tell you how you can retire a millionaire from this job young lady.”
He went into delineating my benefits, stock options, and it all turned into a big blur for me. I saw dollar signs. It sounded pretty good to a 26 year old. So, that’s how initially I was told it wasn’t altruistic.
Adam Omkara: And you said you were actually trained to misinform people- Can you elaborate on that?
Gwen: Well, initially when you start pharmaceutical sales training you are taken into the home office for a sort of ‘indoctrination’ that’s 2-6 weeks of intensive training. That’s where the industry turns representatives into psychological profilers and people pleasers. The reps learn how to be people analyzers, so they know how to best influence people. We were taught in training sessions called ‘knee to knees’ and ‘toe to toes’ where you have a line of reps that play the doctor and opposing lines that play the rep position.
You have to learn verbatim the company’s position and their marketing lines- you can’t even vary from that. You practice and practice until it flows naturally and doesn’t sound rehearsed.
I started recognizing really that I was being trained to divert doctor’s attention away from his/her concerns. So, I was learning to misinform and disinform- to counter the doctor’s valid concerns. I wasn’t trained to say “this drug is bad for that patient” or “watch out for this drug’s interaction with that one." Any information perceived as a negative was always being candy coated.
In fact many times we would be called into a meeting when a new sales piece was being introduced. Managers would ask us questions on what aspects of the piece we received the most objections on. What were the parts that raised the most concern? After we gave the marketing department that feedback, the next period they would come up with a different layout that had manipulated and minimized the objectionable data. So, it was a constant set of circumstances where I began to see that I wasn’t allowed to give good information and I wasn’t given good information to share.
The industry knows that many of their drugs aren’t safe and that they don’t heal people. In fact, some drugs are designed to make symptoms worse later on.
When I started becoming pro-active and began to ask too many critically intelligent questions, management objected and discouraged me. I was frequently met with answers such as “We do it that way because we can", or "We sell more pills that way.”
It was apparent my inquiries were not welcomed!
It was almost like being in the military, in fact, many of my ex-managers had been in the military. Many are hired because they have great work ethics and they don’t ask a lot of questions. Military personnel are used to working on a ‘need to know’ basis.
Adam Omkara: How did you come to an awakening towards the industry. Did it all hit you all of the sudden, or was it a slow process?
Gwen: I realized early on I was in a position where I could harm people; In a position where I could literally take lives. My grand realization arrived when I started promoting a specific new drug.
I went to a national sales meeting for this new drug launch and was told the wonders on how it was going to help people. We immediately were sent out into our individual territories to get support for the new drug with key prescribing physicians.
The dark secrets of the drug industry
The dark truth of the drug industry
Drug reps are given profiles of all the physicians in the territory on what their ‘writing habits’ are, i.e. their general personality, their prescribing habits like whether they are high volume prescribers or early adopters, or late adopters/skeptics.
Reps have all this information available before making a sales call so that they know how to approach the doctor and can develop a sales strategy.
So there was one doctor in my territory that was profiled as a “late adopter/skeptic.” That meant he was going to be difficult for me to get him to prescribe my new drug.
The marketing plan developed at launch emphasized to the sales force that as a last ditch effort, if a doctor didn’t want to write prescriptions for the new product, then the rep was to ask for just one patient- the most difficult patient that the doctor had. The theory was that if the drug worked for them, then the doctor would be more likely to use it in his broader practice later.
I did my presentation and the doctor told me his policy was he didn’t prescribe a new drug until it’s been on the market for at least a year. He had been burned on new drugs before.
However, with some hesitation he agreed to try it in his most difficult patient who had failed all other therapies and I left him samples.
Some time later I got a call from my district manager. I was being sent out to gather information for an Adverse Drug Reaction (ADR) report, as there has been a death in my territory from our new drug and it was a patient of that doctor. And guess what- it was his mother! She had gone into renal failure and died from complications in dialysis. I was devastated!
After I went to get the ADR info, it took me almost 6 months to work up the nerve to go see that man again and look him in the eye. I was acutely aware that it had been my over-zealous and persistent marketing of the product that had influenced him to do something against his better judgment and, as a consequence, his own mother had paid with her life!
I’ll never forget his angry, terse remark to me, “Well, I see you all put a lot more effort into your marketing plan than you did your drug research and development!” What could I say to him after that?
That was my very first clue as a young rep that my job had serious ramifications.
Once this happened more and more things started falling into place. So with that awareness I began to see the job and industry with new eyes…
Adam Omkara: And no one seems to questions this? Why don’t you think there is more of this awakening or questioning? Representatives, psychiatrists, doctors, managers? Is there some desensitization process that comes into play that’s very effective? Where does the disconnect come into play and how is it sustained?
Gwen: Yes, there is definitely a desensitization process. A re-programming if you will. The indoctrination is usually done at the home office during the initial training and is similar to how they do boot camp in the military. They tear you down physically and psychologically, reps are kept up late nights studying for exams, preparing presentations, filming videos, deprived of sleep, deprived of good nutrition, required to dress to the nines and constantly compete with one another as they are being watched and evaluated in the corporate fish bowl.
It’s a very psychologically grueling, but effective grooming environment.
Then when they release you back into your sales territory, you have this false sense of bravado feeling like you’re someone special who is going to go out and help the world. It’s literally a brainwashing process.
What they are effectively doing is trying to weed out the mavericks and break the weak ones. The one’s who can’t handle the job long term and, therefore, will be a wasted investment.
Adam Omkara: Do you know if the same basic training policy is upheld for other companies?
Gwen: I worked for five different companies and it happened in every single one. And I was no flunkee who lost my job and then started bashing the industry. I was the best of the best and performed at the top 3% in each company that I worked for full time.
Usually, as soon as a rep starts asking too many questions or makes unnecessary waves with management they are easily dispensed of and told there are plenty more eligible people behind them waiting to take their job. The only reason I was tolerated was because of how valuable I was to them.
I always made my district and managers look good at the bottom line.
Adam Omkara: And what about the psychiatrists and that industry? Do they not question?
Gwen: You really want me to be honest? The pharmaceutical industry makes so much fun of the psychiatric profession that it’s not even funny. They actually refer to psychiatrists as ‘drug whores.’ The reason they call them that is because they have no loyalty to any one company or product, it’s whoever is paying them at the time.
I was told in the initial training I received to sell antipsychotic drugs that most psychiatrists got into the field of psychiatry in order to figure out why they were so screwed up. There were definitely some very odd birds! So yeah, they were not held in very high regard. My colleagues and I looked down on them as though they were a ‘lower class’ quasi-physician. Because we knew that they didn’t do anything scientifically, it was all subjective diagnosis in nature, dependent on third-party observation of symptoms.
So they were easy to sell drugs to. Most psychiatrists are so ego-driven they would literally recommend anything when given the appropriate sales pitch!
In this day and age, most psychiatrists don’t use talk therapy anymore- just 15 minute appointments, what are your symptoms, try this and come back in a month. You’re lucky if you can get counseling these days (under coverage) and children rarely get it.
So, you can see there is a huge incentive to continue the psychopharmacologic-based treatment paradigm. Because if this huge house of cards actually implodes there will be all these doctors that have no way to practice in psychiatry anymore. Without drug therapy, how would they practice?
Monday, March 28, 2011
Interventional radiologists advance MS research: Vein-opening treatment safe
Early study of 231 patients details safety of using angioplasty to widen internal jugular and azygos veins; doctors hope results encourage more research to explore minimally invasive treatment options for those with multiple sclerosis
IMAGE: This is Gary P. Siskin, M.D., FSIR.
Click here for more information.
CHICAGO, Ill. (March 28, 2011)—Understanding that angioplasty—a medical treatment used by interventional radiologists to widen the veins in the neck and chest to improve blood flow—is safe may encourage additional studies for its use as a treatment option for individuals with multiple sclerosis, say researchers at the Society of Interventional Radiology's 36th Annual Scientific Meeting in Chicago, Ill.
"Angioplasty—the nonsurgical procedure of threading a thin tube into a vein or artery to open blocked or narrowed blood vessels—is a safe treatment. Our study will provide researchers the confidence to study it as an MS treatment option for the future," said Kenneth Mandato, M.D., an interventional radiologist at Albany Medical Center in Albany, N.Y. In a retrospective study, 231 MS patients (age range, 25 to 70 years old; 147 women, 84 men) underwent this endovascular treatment of the internal jugular and azygos veins with or without placement of a stent (a tiny mesh tube). "Our results show that such treatment is safe when performed in the hospital or on an outpatient basis—with 97 percent treated without incident," Mandato noted. He added, "Our study, while not specifically evaluating the outcomes of this endovascular treatment, has shown that it can be safely performed, with only a minimal risk of significant complication. It is our hope that future prospective studies are performed to further assess the safety of this procedure." Complications included abnormal heart rhythm in three patients and the immediate re-narrowing of treated veins in four patients. All but two of the patients were discharged within three hours of receiving this minimally invasive treatment.
About 500,000 people in the United States have MS, generally thought of as an incurable, disabling autoimmune disease¬ in which a person's body attacks its own cells. "There are few treatment options that truly improve the quality of life of those with the disease, and some of the current drug treatment options for MS carry significant risk," said Mandato. In 2009, Paolo Zamboni, a doctor from Italy, published a study that suggested that a blockage in the veins that drain blood from the brain and spinal cord and return it to the heart (a condition called chronic cerebrospinal venous insufficiency or CCSVI) might contribute to MS and its symptoms. The idea is that if these veins were widened, blood flow may be improved, which may help lessen the severity of MS-related symptoms.
The Society of Interventional Radiology issued a position statement last fall supporting high-quality clinical research to determine the safety and effectiveness of interventional MS treatments, recognizing that the role of CCSVI in MS and its endovascular treatment by an
IMAGE: This is Kenneth Mandato, M.D.
Click here for more information.
interventional radiologist via angioplasty and/or stents to open up veins could be transformative for patients. "This is an entirely new approach to the treatment of patients with neurologic conditions, such as multiple sclerosis. The idea that there may be a venous component that causes some symptoms in patients with MS is a radical departure from current medical thinking," said Gary P. Siskin, M.D., FSIR, an interventional radiologist and chair of the radiology department at Albany Medical Center and the co-chair of the SIR research consensus panel on MS that was held in October.
"It is important to understand that this is a new approach to MS. As a result, there is a healthy level of skepticism in both the neurology and interventional radiology communities about the condition, the treatment and the outcomes," said Siskin. "Interventional radiologists have been performing venous angioplasty for decades and have established themselves as pioneers in this area of vascular intervention. Patients are learning about this therapy and the role of interventional radiology in venous angioplasty through the Internet. They are discussing it among themselves—through blogs and social networking sites—and then turning to interventional radiologists for this treatment," he noted. "This is a new entity and one where researchers are clearly very early in their understanding of both the condition and the treatment," added Siskin.
SIR's position statement agrees with MS advocates, doctors and other caregivers that the use of any treatment (anti-inflammatory, immunomodulatory, interventional or other) in MS patients should be based on an individualized assessment of the patient's disease status, his or her tolerance of previous therapies, the particular treatment's scientific plausibility, and the strength and methodological quality of its supporting clinical evidence. "When conclusive evidence is lacking, SIR believes that these often difficult decisions are best made by individual patients, their families and their physicians," notes the society's position paper, "Interventional Endovascular Management of Chronic Cerebrospinal Venous Insufficiency in Patients With Multiple Sclerosis: A Position Statement by the Society of Interventional Radiology, Endorsed by the Canadian Interventional Radiology Association." SIR stresses the importance for MS patients to continue an ongoing dialogue with their neurologists to discuss their treatment care.
While the use of angioplasty and stents cannot be endorsed yet as a routine clinical treatment for MS, SIR agrees that the preliminary research is very promising and supports studies aimed at understanding the role of CCSVI in MS, at identifying methods to screen for the condition and at designing protocols for exploratory therapeutic trials. "If interventional therapy proves to be effective, MS patients should be treated by doctors who have specialized expertise and training in delivering image-guided venous treatments," said Siskin. Interventional radiologists pioneered angioplasty and stent placements and use those treatments on a daily basis in thousands of patients with diverse venous conditions.
Mandato noted that research still needs to be done concerning patient selection, technique and the outcomes after this procedure, including improvement in symptoms and quality of life and the durability of the response.
Early study of 231 patients details safety of using angioplasty to widen internal jugular and azygos veins; doctors hope results encourage more research to explore minimally invasive treatment options for those with multiple sclerosis
IMAGE: This is Gary P. Siskin, M.D., FSIR.
Click here for more information.
CHICAGO, Ill. (March 28, 2011)—Understanding that angioplasty—a medical treatment used by interventional radiologists to widen the veins in the neck and chest to improve blood flow—is safe may encourage additional studies for its use as a treatment option for individuals with multiple sclerosis, say researchers at the Society of Interventional Radiology's 36th Annual Scientific Meeting in Chicago, Ill.
"Angioplasty—the nonsurgical procedure of threading a thin tube into a vein or artery to open blocked or narrowed blood vessels—is a safe treatment. Our study will provide researchers the confidence to study it as an MS treatment option for the future," said Kenneth Mandato, M.D., an interventional radiologist at Albany Medical Center in Albany, N.Y. In a retrospective study, 231 MS patients (age range, 25 to 70 years old; 147 women, 84 men) underwent this endovascular treatment of the internal jugular and azygos veins with or without placement of a stent (a tiny mesh tube). "Our results show that such treatment is safe when performed in the hospital or on an outpatient basis—with 97 percent treated without incident," Mandato noted. He added, "Our study, while not specifically evaluating the outcomes of this endovascular treatment, has shown that it can be safely performed, with only a minimal risk of significant complication. It is our hope that future prospective studies are performed to further assess the safety of this procedure." Complications included abnormal heart rhythm in three patients and the immediate re-narrowing of treated veins in four patients. All but two of the patients were discharged within three hours of receiving this minimally invasive treatment.
About 500,000 people in the United States have MS, generally thought of as an incurable, disabling autoimmune disease¬ in which a person's body attacks its own cells. "There are few treatment options that truly improve the quality of life of those with the disease, and some of the current drug treatment options for MS carry significant risk," said Mandato. In 2009, Paolo Zamboni, a doctor from Italy, published a study that suggested that a blockage in the veins that drain blood from the brain and spinal cord and return it to the heart (a condition called chronic cerebrospinal venous insufficiency or CCSVI) might contribute to MS and its symptoms. The idea is that if these veins were widened, blood flow may be improved, which may help lessen the severity of MS-related symptoms.
The Society of Interventional Radiology issued a position statement last fall supporting high-quality clinical research to determine the safety and effectiveness of interventional MS treatments, recognizing that the role of CCSVI in MS and its endovascular treatment by an
IMAGE: This is Kenneth Mandato, M.D.
Click here for more information.
interventional radiologist via angioplasty and/or stents to open up veins could be transformative for patients. "This is an entirely new approach to the treatment of patients with neurologic conditions, such as multiple sclerosis. The idea that there may be a venous component that causes some symptoms in patients with MS is a radical departure from current medical thinking," said Gary P. Siskin, M.D., FSIR, an interventional radiologist and chair of the radiology department at Albany Medical Center and the co-chair of the SIR research consensus panel on MS that was held in October.
"It is important to understand that this is a new approach to MS. As a result, there is a healthy level of skepticism in both the neurology and interventional radiology communities about the condition, the treatment and the outcomes," said Siskin. "Interventional radiologists have been performing venous angioplasty for decades and have established themselves as pioneers in this area of vascular intervention. Patients are learning about this therapy and the role of interventional radiology in venous angioplasty through the Internet. They are discussing it among themselves—through blogs and social networking sites—and then turning to interventional radiologists for this treatment," he noted. "This is a new entity and one where researchers are clearly very early in their understanding of both the condition and the treatment," added Siskin.
SIR's position statement agrees with MS advocates, doctors and other caregivers that the use of any treatment (anti-inflammatory, immunomodulatory, interventional or other) in MS patients should be based on an individualized assessment of the patient's disease status, his or her tolerance of previous therapies, the particular treatment's scientific plausibility, and the strength and methodological quality of its supporting clinical evidence. "When conclusive evidence is lacking, SIR believes that these often difficult decisions are best made by individual patients, their families and their physicians," notes the society's position paper, "Interventional Endovascular Management of Chronic Cerebrospinal Venous Insufficiency in Patients With Multiple Sclerosis: A Position Statement by the Society of Interventional Radiology, Endorsed by the Canadian Interventional Radiology Association." SIR stresses the importance for MS patients to continue an ongoing dialogue with their neurologists to discuss their treatment care.
While the use of angioplasty and stents cannot be endorsed yet as a routine clinical treatment for MS, SIR agrees that the preliminary research is very promising and supports studies aimed at understanding the role of CCSVI in MS, at identifying methods to screen for the condition and at designing protocols for exploratory therapeutic trials. "If interventional therapy proves to be effective, MS patients should be treated by doctors who have specialized expertise and training in delivering image-guided venous treatments," said Siskin. Interventional radiologists pioneered angioplasty and stent placements and use those treatments on a daily basis in thousands of patients with diverse venous conditions.
Mandato noted that research still needs to be done concerning patient selection, technique and the outcomes after this procedure, including improvement in symptoms and quality of life and the durability of the response.
CCSVI Fund Raising
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Denise Manley's Fundraising Page Page Creator: Denise Manley
Event: Denise Manley's Fundraising Page
Page Closes Wednesday, June 15, 2011
Fundraising Page Image
Denise Manley, Liberated and healing!
About my nonprofit:
Capital Region Medical Research Foundation Inc
Fundraising target: $20,000.00
Total raised so far: $15,531.92
I want to raise money too
I want to raise money:
* for this nonprofit
* for another nonprofit
Fundraising progress
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Spread the Word
My personal message:
Many of you know me, Denise Manley, and my story about my struggle in life with secondary progressive multiple sclerosis for the last 20 years and my struggle to get testing and treatment for CCSVI. If you haven't ever met me and want to to really see what angioplasty can possibly do for a person with MS take some time to view my youtube videos of me before and after my procedure with Dr. Gary Siskin. I can be found at http://www.youtube.com/user/9gabbycats .
I have a personal plea for donations towards Dr. Siskin’s work which has started and will show that people with Multiple Sclerosis are suffering from CCSVI and it's treatable. Our fundraising goal is to keep asking for help until the day comes that the entire medical field realize that CCSVI untreated causes multiple sclerosis or at least many of the problems we suffer from.
Dr. Gary Siskin is one of our many pioneer heroes in the treatment of CCSVI. I would like us all to help insure that all the necessary study and research will be well funded and move forward. I will not be completely "Liberated" until all people with MS have the option to be tested and treated for this venous disease and malformation.
To become a participant in a study please follow this link and read the criteria and expectaions.
If you would like to participate please follow the instructions on the study link.
http://clinicaltrials.gov/ct2/show/NCT01201707?term=ccsvi&rank=2
This study is currently recruiting participants. Verified by Community Care Physicians, P.C., August 2010
Home | Who we are | Sign in
See the new view of this page
Denise Manley's Fundraising Page Page Creator: Denise Manley
Event: Denise Manley's Fundraising Page
Page Closes Wednesday, June 15, 2011
Fundraising Page Image
Denise Manley, Liberated and healing!
About my nonprofit:
Capital Region Medical Research Foundation Inc
Fundraising target: $20,000.00
Total raised so far: $15,531.92
I want to raise money too
I want to raise money:
* for this nonprofit
* for another nonprofit
Fundraising progress
25% 50% 75% 100%
Spread the Word
My personal message:
Many of you know me, Denise Manley, and my story about my struggle in life with secondary progressive multiple sclerosis for the last 20 years and my struggle to get testing and treatment for CCSVI. If you haven't ever met me and want to to really see what angioplasty can possibly do for a person with MS take some time to view my youtube videos of me before and after my procedure with Dr. Gary Siskin. I can be found at http://www.youtube.com/user/9gabbycats .
I have a personal plea for donations towards Dr. Siskin’s work which has started and will show that people with Multiple Sclerosis are suffering from CCSVI and it's treatable. Our fundraising goal is to keep asking for help until the day comes that the entire medical field realize that CCSVI untreated causes multiple sclerosis or at least many of the problems we suffer from.
Dr. Gary Siskin is one of our many pioneer heroes in the treatment of CCSVI. I would like us all to help insure that all the necessary study and research will be well funded and move forward. I will not be completely "Liberated" until all people with MS have the option to be tested and treated for this venous disease and malformation.
To become a participant in a study please follow this link and read the criteria and expectaions.
If you would like to participate please follow the instructions on the study link.
http://clinicaltrials.gov/ct2/show/NCT01201707?term=ccsvi&rank=2
This study is currently recruiting participants. Verified by Community Care Physicians, P.C., August 2010
Sunday, March 27, 2011
Let's get movng
New Address
Can't remember if I told
You, but I have moved out from
Beggars Alley , located at
2 Poverty Lane at the corner of Down and Out Circle.
As of today, I have a brand new home ..
My new address is
Living Well on 231 Abundance Terrace,
Located at the corner of
Blessings Drive and Prosperity Peak .
It's in the God Can neighborhood.
No longer will I allow myself to travel to the other side of town on
Begging Peter to pay Paul Route,
Located at a dead end
Intersection called I Don't Have ,
Which connects with Borrowers Junction!
I no longer hang out at Failure's Place,
Near Excuses Avenue ,
Next to Procrastination Point.
I've moved to an upscale community called
Higher Heights
With unlimited potential and opportunities for me to succeed.
Life is good because
God is good!
Care to change your address?
There are many vacancies!
Can't remember if I told
You, but I have moved out from
Beggars Alley , located at
2 Poverty Lane at the corner of Down and Out Circle.
As of today, I have a brand new home ..
My new address is
Living Well on 231 Abundance Terrace,
Located at the corner of
Blessings Drive and Prosperity Peak .
It's in the God Can neighborhood.
No longer will I allow myself to travel to the other side of town on
Begging Peter to pay Paul Route,
Located at a dead end
Intersection called I Don't Have ,
Which connects with Borrowers Junction!
I no longer hang out at Failure's Place,
Near Excuses Avenue ,
Next to Procrastination Point.
I've moved to an upscale community called
Higher Heights
With unlimited potential and opportunities for me to succeed.
Life is good because
God is good!
Care to change your address?
There are many vacancies!
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